During gestation the fetus develops within the confines of the gestational sac. A pair of juxtaposed, resilient membranous structures define the outer margins of the gestational sac: an inner amniotic membrane (amnion) and an outer chorionic membrane (chorion). Following birth, the gestational sac is no longer necessary and is separated from the newborn by severing of the umbilical cord. Following parturition the gestational sac, commonly referred to as the afterbirth, is disposed of as medical waste. However, the tissues of the afterbirth are increasingly being harvested as sources of valued biomedical materials. This is particularly true of the amnion.
The amnion was first used nearly a century ago to treat granulating wounds and burned or ulcerated skin surfaces. More routine use of amnion and chorion began in the 1950's, targeting caustic, chemical and flame burns (Dj 1950, Kirschbaum 1955, Perfil'Ev 1959, Pigeon 1960, Scheibe 1966, Sterling 1956, Zubovich 1963). The value of amnion in medical procedures is highlighted by the proposal to establish an amnion bank in the 1960's (Dino et al. 1966).
Contemporary medicine has witnessed an explosive increase in the utility of amniotic membrane. Vaginal reconstruction (Ashworth et al. 1986, Mhaskar 2005, Morton et al. 1986, Tancer et al. 1979, Zafar et al. 2007), surgical correction of male urethra strictures (Koziak et al. 2004) and treatment of venous leg ulcers (Zubovich 1963) have all employed human amniotic membrane. However, the most prevalent use of amnion in surgical procedures involves the eye (Kaup et al. 2008).
Amniotic membrane transplantation for the treatment of ocular surface disorders has become routine within the past decade. Thermal and chemical burns, pterygium and other disorders of the eye have been treated with amniotic membrane (Park et al. 2008, Sangwan et al. 2007, Srinivas et al. 2007, Tejwani et al. 2007). Ocular surface reconstruction employing amniotic membrane frequently improves patient outcome and reduces associated pain. In many countries, Eye Banks collect and preserve amniotic membrane to address shortages of corneas donated for transplantation.
Recent interest in the amnion and chorion has been heightened by the demonstration of stem cell populations within these tissues (Kim et al. 2007, Kim et al. 2006, Marcus et al. 2008, Marcus et al. 2008, Miki et al. 2007, Miki et al. 2006, Soncini et al. 2007)]. The concept of ‘regenerative medicine’, repairing or replacing diseased tissue through stem cell therapies, has moved forward to the clinic. Multiple stem cell populations have been identified in the amnion and chorion. Any, or all, may have future clinical utility, potentially playing a role in regenerative medicine approaches.
Irrespective of ultimate use, methodologies and/or devices that facilitate the harvest and, in some cases, storage of amnion and chorion would prove beneficial to the health care community. Contemporary methodologies, using standard medical cutting devices such as scalpels and scissors to generate samples of amnion and chorion are cumbersome. As the demand for these biological materials grows, novel approaches to sample procurement will be needed. The present invention describes a hand-held device that simplifies the harvest of amnion and chorion from the afterbirth. Additional features that facilitate subsequent storage of the isolated biological materials are likewise described.